Fitness to practise support for pharmacy applications

In summary: Fitness to practise requirements apply both to new pharmacy applicants and to existing contractors subject to review. An ICB can refuse a market entry application, or commence removal proceedings against an existing contractor, on fitness grounds. The consequences — conditional inclusion, suspension or removal from the pharmaceutical list — are serious and potentially irreversible. TI Pharmacy Consultancy provides guidance and documentation support for all fitness-related matters.

Fitness to practise matters arise both in new applications and in reviews of existing contractors. The consequences of getting this wrong — conditional inclusion, removal, or disqualification — are serious. TI Pharmacy Consultancy provides guidance and documentation support throughout.

What we do

  • Advising on fitness requirements for new applicants and superintendents
  • Preparing fitness documentation where an adverse finding is disclosed
  • Supporting conditional inclusion reviews and compliance with conditions
  • Advising existing contractors facing fitness review by ICBs
  • Coordination with legal advisers where necessary

How it works

Initial assessment

We assess the fitness issue and advise on the most appropriate approach.

Documentation support

We help prepare clear, complete fitness disclosures and supporting material.

ICB engagement

We manage communications with the ICB or committee throughout the review.

Ongoing support

We advise on compliance with any conditions imposed following determination.

Frequently asked questions

Under the NHS (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013, an applicant for a new pharmacy contract — or a new owner in a change of ownership — must satisfy the ICB that they are fit to be included in the pharmaceutical list. Fitness requirements cover criminal convictions, regulatory proceedings, professional history and other matters. The ICB has discretion in how it weighs fitness information. TI Pharmacy Consultancy advises on fitness requirements and helps prepare complete, well-presented fitness information.

A criminal conviction or adverse regulatory finding does not automatically disqualify a pharmacy applicant, but it must be disclosed and will be considered by the ICB. The weight given to it depends on the nature of the matter, how long ago it occurred and what has happened since. A poorly presented or incomplete disclosure is more likely to result in refusal or conditions than a well-prepared one. TI Pharmacy Consultancy advises on how to present fitness information where a concern exists.

Conditional inclusion is where the ICB grants a pharmacy application subject to conditions — for example, requiring regular reporting, supervision arrangements or restrictions on the services provided. Conditions can be imposed where the ICB has fitness concerns but does not consider them serious enough to refuse the application outright. TI Pharmacy Consultancy advises on compliance with conditions and applications to vary or remove them.

Yes. The ICB can commence proceedings to remove an existing contractor from the pharmaceutical list if it has fitness concerns. This is a serious step with significant commercial consequences. The contractor has the right to make representations and to appeal. TI Pharmacy Consultancy advises existing contractors facing fitness review and manages the representations and appeal process.

No. From 1 October 2024, references from named referees are no longer required as part of NHS pharmacy market entry applications or fitness information submissions in England. This change applies to both new applications and change of ownership applications. Applications submitted after this date should not include referee details.

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